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Clinical
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19000CH5 Requisition #
Careers That Change Lives

The Principal Statistician will be responsible for statistical aspects of study design and analysis of data from complex clinical studies conducted for regulatory approval or marketing purposes.  This includes responsibility for design of studies, calculating of sample size and power, writing of statistical portions of protocol and statistical analysis plan, review of protocol and case report forms, analysis and interpretation of data, and preparation of relevant sections of regulatory submissions, reports, and manuscripts.  Work will generally be self-directed, but will be reviewed by the Manager at key time points.  The Principal Statistician will be expected to provide leadership to study teams and to other statistical staff.

Impact patient outcomes.  Come for a job, stay for a career.

 

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

PAIN THERAPIES offers solutions — from early interventional procedures to implantable surgical technologies — that treat chronic pain as well as pain from spinal fractures, cancer and severe spasticity.

 
A Day in the Life
  • Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met.  This requires calculation of sample size and power, as well as possible determination of appropriate design assumptions from published literature.
  • Prepares relevant sections of protocols, especially those detailing the plans for data analysis, and justification for the sample size. Reviews entire protocol for consistency.
  • Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately.
  • Identifies potential threats to study credibility and validity, and works with study team to prevent, track, and manage potential problems.
  • Writes the statistical analysis plan for the study, if required.  Also writes error-checking requirements for the study data.
  • Takes a leadership role in responding to relevant questions from FDA,  FDA Advisory Panels, and/or other regulatory agencies, and in negotiations with regulatory agencies regarding study design and interpretation. 
  • Uses a variety of statistical methods and software tools to analyze and display data from clinical and other studies, including more advanced methods.  Methods must be appropriate for the kind of data collected, and required assumptions must be tested.
  • Interprets statistical and clinical findings, and ensures that regulatory submissions, reports, and manuscripts accurately reflect the data collected.
  • Validates and provides clear documentation of analysis programs.
  • Writes Results and Methods sections of reports and manuscripts as needed.
  • Consults with other (e.g. non-clinical) staff on statistical and analysis issues.
  • Lead development of policies and procedures for the department and the statistics group.
  • Mentor and train Statisticians and/or Senior Statisticians in their job duties and responsibilities.
  • Attends and contributes to project and department meetings.

Must Have: Minimum Qualifications

  • Bachelors degree required Biostatistics or Statistics
  • Minimum of 7 years of experience in analysis of data from clinical studies and design of clinical trials, or advanced degree with a minimum of 5 years experience in analysis of data from clinical studies and design of clinical trials.
 
Nice to Have
  • Experience in clinical studies from the design through approval stages in the medical device or pharmaceutical industries. 
  • Participation in FDA regulatory meetings, especially panel preparation and presentation. 
  • Strong applied statistical skills, including survival analysis, regression modeling, Bayesian methods, longitudinal analysis (including mixed models), interim analysis, missing data strategies and multiple testing strategies.
  • Advanced programming skills in SAS, or another statistical analysis package
  • High level of knowledge of clinical trial methods and execution
  • High Degree of expertise regarding research data management
  • High level of competency in Windows environment and with Microsoft Office Tools (Word, Excel)
  • Demonstration of good oral and written communication skills
  • Well-developed interpersonal skills and collaborations with multiple functions
  • Demonstration or evidence of leadership competencies.
  • Relational database function, and SAS Proc SQL
 
Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

 

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 
About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

 

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

 
EEO

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

 

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here:http://www.uscis.gov/e-verify/employees

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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